NCT01617135

Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations ("Off Episodes")

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

Detailed description

Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CVT-301
DRUG	Placebo
DRUG	Sinemet (carbidopa/levodopa)
DRUG	CVT-301

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-06-12
• Last updated: 2017-07-27

Locations

7 sites across 3 countries: Israel, Serbia, United Kingdom